New Cholesterol Drugs Gain Entry To Large Formulary

The two big and expensive new cholesterol drugs that everyone is talking about have both been added to the national preferred formulary of Express Scripts, the nation’s largest pharmacy benefit manager.

The drugs– alirocumab (Praluent, from Regeneron and Sanofi) and evolocumab (Repatha, from Amgen)– are potent but expensive drugs that inhibit PCSK9 and dramatically lower LDL cholesterol. Both drugs have a wholesale acquisition cost of more than $14,000 a year. Express Scripts did not state the precise amount it will pay for each drug.

But the company did project that the overall market for the drugs will not exceed $10 billion in 2016, which would amount to $750 million for the company’s clients. This amount is “far lower than industry forecasts,” according to the company. The Express Scripts preferred national formulary covers about 25 million people in the US. A company spokesman told me that the $10 billion is a maximum estimate which it feels confident will not be exceeded. The company would not estimate how much lower the total market would likely be in 2016.

Express Scripts also announced that the drug makers had agreed to limitations in future price increases. These increases have been the subject of considerable criticism in response to several widely publicized recent cases.

Express Scripts said it expected to control costs “with a combination of discounts and a rigorous utilization management program” for both drugs. Last week, as reported here,  the company revealed that it had rejected the majority of prescriptions for the drugs “because patients did not meet required medical criteria.”

 

Both drugs have been approved for use in patients with clinical atherosclerotic cardiovascular disease and heterozygous familial hypercholesterolemia. They have not been approved for use in patients who are statin intolerant. One of the drugs (Repatha) was also approved for the few patients who have homozygous familial hypercholesterolemia.

 

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